Skip to Main Content

Advertisement intended for health care professionals

Skip Nav Destination

Venetoclax Receives Priority Review for CLL

December 30, 2021

The U.S. FDA granted breakthrough therapy designation for the investigational drug venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory CLL.

The drug is an inhibitor of the B-cell lymphoma-2 protein. In April 2015, single-agent venetoclax was granted breakthrough therapy designation for the treatment of relapsed/refractory CLL in patients with the del17p mutation.

The FDA's decision was based in part on results from the phase II, open-label, single-arm, multicenter M13-982 study, which evaluated the safety and efficacy of venetoclax in 107 patients with relapsed/refractory or previously untreated CLL. The overall response rate was 79.4 percent among the patients receiving venetoclax and, at one-year, the rate of progression-free survival was 72 percent and the rate of overall survival was 86.7 percent.

The study also included a subset of 45 patients who were analyzed for the level of minimal residual disease (MRD) in peripheral blood and/or bone marrow. Among this cohort, 18 patients achieved MRD-negativity.

The most common treatment-related AEs included fever (7%), low red blood cell count as a result of immune response (7%), pneumonia (6%), and low white blood cell count with fever (5%). The most common grade 3/4 AEs were low white blood cell count (40%), low red blood cell count (18%), and low platelet count (15%). In addition, grade ≥3 infection occurred in 20 percent of patients.

Sources: Genentech press release, January 12, 2016; AbbVie press release, January 20, 2016.

Advertisement intended for health care professionals

Connect with us:

CURRENT ISSUE
November 2024

Advertisement intended for health care professionals

Close Modal

or Create an Account

Close Modal
Close Modal

Advertisement intended for health care professionals